Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Trial Parameters
Brief Summary
The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.
Eligibility Criteria
Inclusion Criteria: 1. A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following: 1. a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and 2. at least 1 electrocardiographically documented episode within 12 months prior to enrollment 2. Adults who are ≥18 and ≤80 years of age on the day of enrollment. 3. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study. Exclusion Criteria: 1. Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration \> 7 days 2. AF that required three (3) or more distinct cardioversions in the preceding 12 months. 3. LA anteroposterior \> 5.0 cm (by MRI, CT, or TTE) 4. Any of the following procedure